Contract Manufacturing Regulatory Approval Round-Up
Evonik gets the thumbs up from the MHRA, Recipharm's approved by Japan and Simcere passes the Chinese regulatory test – welcome to Outsourcing-Pharma’s round-up of GMP accreditation.
Archives for March 26, 2013
CRO Pays $22.5M to Dr. Reddy’s to Settle Lawsuit
Canada-based CRO Nordion paid $22.5 million last week to settle a lawsuit by Dr. Reddy’s Laboratories claiming Nordion breached its lab services agreement.
GSK Developing Low-Cost Polio Vax Manufacturing Tech with NIBSC
GSK is working on a low-cost manufacturing platform it will use to produce inactivated polio vaccines (IPV) for developing countries.
Shire's Vision Strengthened with $160m Acquisition
Shire says it is laying down a foundation into the specialty ophthalmology field following its second acquisition in a matter of weeks.
Update
Propofol Lethal Injections Blocked as Teva and Hospira Re-Enter Market
Both Teva and Hospira have pledged to restrict distribution of propofol as a lethal injection ingredient while production of the drug recommences.
Bankrupt PRACS’s Payments to Uncompensated Trial Subjects ‘Up to Trustee’
The PRACS Institute has filed for bankruptcy after closing down its US and Canadian research sites, but the question of whether unpaid trial participants will receive payment for their work is still up in the air.
CRO’s China Lab Hit With Form 483 Under US FDA’s HSP/BIMO Initiative
Philadelphia-based CRO Frontage has received a Form 483 for “minor” issues related to its bioanalytical lab in Shanghai, China, a spokesman told us.